Alternative Name: Levosert (U.K.); Erlacela (Portugal); Donasert (Romania); Avibela
Description: LILETTA is the brand name for the levonorgestrel-releasing intrauterine system (LNG-IUS) marketed by Medicines360 and Actavis in the U.S., where it is approved for 3 years of use for contraception.
Delivery Method: Intrauterine
Duration Type: Long-acting
Duration: 4 years
Dose: 52 mg
Active Pharmaceutical Ingredient (API):
Inactive material: drug reservoir is silicone base; T-frame is low density polyethylene (LDPE), etc. See footnote
Multipurpose Preventive Technology (MPT): No
Project Phase: Limited Market Availability
Development Stage: SRA/WHO PQ Approved
Active Development: Yes
- Medicines360 received U.S. FDA approval for Liletta in February 2015, with a use duration of 3 years. The product launched in the U.S. in April 2015. Medicines360 and Allergen filed a supplemental new drug application to the US FDA to extend Liletta's use duration to 4 years; the application was approved in August 2017.
- The product is also approved in more than a dozen countries in Europe, including in the U.K. for 3 years of contraception and treatment of menorrhagia.
- In 2014, a public-private partnership was launched between Medicines360, FHI 360 and Marie Stopes International (MSI) to support the development of an introduction strategy for the product in Kenya.
- A study of Liletta's effectiveness over the course of ten years is underway. Preliminary results published after 5 years indicating Liletta is still effective at 5 year mark.